Title: Quality Manager
Our client a leading global company specializing in custom packaging solutions for the medical device and pharmaceutical industries is seeking a Quality Manager for their location in the Allentown PA area. The company focuses on designing and manufacturing highquality packaging using advanced plastic manufacturing technology and stringent quality control measures.
Position Overview
Role: As the Quality Manager you would be responsible for developing establishing and maintaining QA programs policies and processes and ensuring the quality performance of our products by performing the following duties personally or through subordinate supervisors and/or the management team.
Responsibilities and Functions:
- Direct and coordinate quality projects of major magnitude and scope providing significant guidance and approval regarding technical strategies and approaches.
- Develops and monitors department budgets to maximize investments increase efficiencies and ensure the quality of our product.
- Ensures processes needed for the QMS are established implemented and maintained.
- Manages the following functions or tasks directly or through subordinates: Management Review Supplier Quality / SCAR Calibration NCM Control Document Control CAPA External QMS Audits (Customer Notified Bodies) Corporate Internal QMS Audits Inprocess Inspection and other duties and assignments as directed by Management.
Qualifications:
Education:
- High School Diploma BS in Engineering Preferred
Experience:
- Required: 5 years in a plasticsrelated manufacturing environment
- cGMP/cGDP Experience
- ASQ CQE Certification a plus
- Quality Engineering (i.e. DOE Inference Tests Normality/Capability Analyses Correlation Studies Gage RR etc)
- Validation / PPAP / Regulatory Compliance Reach/Rohus Etc.
- ISO 13485 knowledge
Other requirements:
- Excellent organizational and oral/written communication skills
- Maintain a positive work atmosphere by behaving and communicating in a manner that fosters a professional environment for clients and associates
- Able to interface effectively at all levels and communicate effectively as part of a team
Benefits:
- 401(k) match program
- Annual bonus
- Dental health and vision insurance
- Paid time off
Location: Allentown PA
If you are interested in this position please apply here send your resume to or contact Matthew at (850).
Required Experience:
Manager